PBAC's latest decision on Abiraterone, enzalutamide: Not recommended (2021). Considered for Proposed amendment to existing PBS listings for castration resistant prostate cancer to remove the requirement that disease be metastatic; previously restricted to metastatic CRPC (mCRPC) following docetaxel failure or unsuitability.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2021
Submissions
1
2021 → 2021
Eligible population
Patients with castration-resistant prostate cancer (CRPC); proposed amendment would have extended eligibility to non-metastatic CRPC (m0CRPC) without the prior docetaxel or unsuitability-for-docetaxel requirement.
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
Other
Economic model
Not modelled
ICER note
This is a resubmission of a listing restriction amendment. No new economic evaluation was performed; the submission concerned a change to clinical criteria only.
Why PBAC said no
Reasons cited in the latest PSD: abiraterone not TGA-registered for non-metastatic CRPC; safety concerns with prolonged prednisone use in earlier disease; no clinical trial evidence for NHAs in low-risk m0CRPC; complex to craft restriction targeting high-risk patients; sponsors did not provide financial impact estimate